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Course content

The objective of the course is to provide the students with an understanding of the framework surrounding the clinical testing of medicine. The participants are to receive insight into the different clinical trial phases, test methodology, testing ethics, quality assurance, as well as how to evaluate results and statistical evaluations.

Learning outcome

The course will give the participants knowledge of guidelines and other relevant documents associated with execution of clinical trials. The participants will get an overview of the different trial phases, research methology, ethical considerations, quality assurance, evaluation of results and statistical methods used in clinical trials.

You will learn basic aspects of clinical trials with regards to study design, ethical considerations, safety reporting, GCP (Good Clinical Practice), distribution of study drug, evaluation of data management and statistical analyses in addition to how to evaluate the results.

You will be able to write a study protocol and be able to initiate as phase IV clinical trial. You will in addition get an overview of how to apply for all necessary approvals needed to start a clinical trial. You will also get an overview of different types of study designs which will make you able to evaluate if a published clinical trial is of good enough quality.

The ethical base of the study is in line with the Helsinki declaration and other international guidelines

Admission

PhD candidates from the University of Oslo should apply for classes and register for examinations through Studentweb.

If a course has limited intake capacity, priority will be given to PhD candidates who follow an individual education plan where this particular course is included. Some national researchers’ schools may have specific rules for ranking applicants for courses with limited intake capacity.

PhD candidates who have been admitted to another higher education institution must apply for a position as a visiting student within a given deadline.

Prerequisites

Formal prerequisite knowledge

A 5 year masterdegree in pharmacy or relevant topic

Overlapping courses

10 credits overlap with FRM5730 – Clinical Drug Trials

Teaching

Lectures, group discussions, and mandatory projects in groups. The main focus of the teaching strategy will be on lectures and group projects and will include study design and planning of clinical trials. The students have to write a clinical protocol in groups of 3-4 students, and reflect on which approvals that is needed in order to start a clinical trial.

Every student must also give an oral presentation for the other students based on one or several review articles.

Access to teaching

A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.

Examination

A four hour written exam/oral exam after the number of students.

The mandatory group project is 1/3 of the total grade, but will not be evaluated separatly.

Examination support material

As of 1 August, 2016, the use of own calculators is no longer permitted. Casio FX-991EX calculators are handed out to all exam candidates at the beginning of the exam.

Language of examination

You may submit your response in Norwegian, Swedish, Danish or English. If you would prefer to have the exam text in English, you may apply to the course administrators.

Grading scale

Grades are awarded on a pass/fail scale. Read more about the grading system.

Explanations and appeals

Resit an examination

This course offers both postponed and resit of examination. Read more:

Withdrawal from an examination

It is possible to take the exam up to 3 times. If you withdraw from the exam after the deadline or during the exam, this will be counted as an examination attempt.

Special examination arrangements

Application form, deadline and requirements for special examination arrangements.

Evaluation

The course is subject to continuous evaluation. At regular intervals we also ask students to participate in a more comprehensive evaluation.

Facts about this course

Credits

10

Level

PhD

Teaching

Every autumn

Cancelled 2018

Examination

Every autumn

Cancelled 2018

Teaching language

Norwegian